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A Regulatory Framework: Life Sciences Strategy Development

Regulatory framework: Curia launches its Life Sciences Industrial Strategy with insights from top-level stakeholders in the sector.

Following several meetings with Life Sciences sector stakeholders, policy institute Curia’s Life Sciences Industrial Strategy Programme for a New Government was launched last month. The third inquiry session focussed on ‘Regulatory Framework’. Chaired by Professor Gillian Leng, Dean and President Elect of the Royal Society of Medicine, Dr Keith Ridge, former Chief Pharmacy Officer for England, and former Health Minister, Professor Ann Keen. Keynote speakers joined the Health, Care and Life Sciences Research Group. These included:

  • Joanne Hackett, Vice President of Health System Services at IQVIA
  • Seamus Harrison, Vice President of Genomics Plc
  • Ian Hudson, former Chief Executive of MHRA
  • Helen Dent, BIVDA Chief Executive
  • Indra Joshi, Founding Ambassador for One Health Tech
  • Keith McDonald, Head of Drug Development Strategy at IQVIA

Genomics: Maximising Potential

Joanne Hackett elaborated on falling costs for initial genomics testing. However, the skills gap and a lack of public awareness are barriers to wider adoption in screening and broader public health. There cannot be precision medicine without population health which needs longitudinal data. After industry and charities have funded large polygenic risk score projects the health system will have more confidence to invest.

“Charities and registries, they often have data that’s not captured in primary care or in a hospital setting. Hospitals have data that’s unique to understanding patient management and flow. Governments collect data that is more about how money is spent in publicly funded systems.”

Joanne Hackett, Vice President of Health System Services at IQVIA

Seamus Harrison agreed that the UK leads on genomics but suggested devoting more time to common disease that impact population health.

“We at genomics have done a trial of putting polygenic risk scores into routine health checks in the NHS that was really well received by patients and physicians.”

Seamus Harrison, Vice President of Geonomics Plc

Maintaining Regulatory Competence

Hudson felt that MHRA has an excellent advisory committee structure with lots of generalists who have some areas of expertise but can then find specific experts through the committee. Given the importance of AI MHRA will need to build internal competency as it cannot solely rely on external experts. McDonald concurred but added that the regulatory committee competes with industry for talent.

The UK’s future lies in international recognition, according to Andrew Davis, but unfortunately, we will recognise other nations, they won’t recognise the UK initially.

Learning from Covid

During Helen Dent’s introduction she argued that the UK needs to reassert its attractiveness to the global economy which, due to the smaller profit potential from the NHS and ambiguous regulation, is not great. She feels that UK regulation is possibly unduly stringent and should align more with global regulation.

“Risk based approach to surveillance, as opposed to a heavy evidence based approach to adoption, would be useful. This would quicken the regulatory process, but ultimately not at the detriment of patients or safety.”

Helen Dent, BIVDA Chief Executive

The exceptional streamlining and swift adoption of technology during covid-19 has stopped. Under the covid methods innovations were granted temporary approval with in-market monitoring which sped up adoption without significant risk to the patients as data gathering methods were there for safety monitoring. Dent theorised that this could be a viable strategy for some innovations.

AI: The Future

Indra Joshi largely focused on AI and its regulation exceptionalism in healthcare. There are lots of new language models and generative AI being developed that regulation is not set up for. Going forward the health system needs to recruit talent that will understand this technology as currently the NHS is around five years behind necessary competency.

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Why are People Leaving?

Joshi found significant frustration with the system due to changing processes, competing organisation guidelines and insufficient budgets. To reverse this consistent leadership is needed. Davis explained that while individuals have left those individuals are mostly still present in industry or other organisations. He wondered how MHRA can work with other organisations to utilise the expertise. He feels that the UK needs to manage population health, fitness and wellbeing (and get that data into the health system), but that there is unclear regulation.

Balancing Risk

Risk should be continually reviewed, Dent says, especially with new technology and AI. The problem is that innovations are assessed centrally and then many different times throughout the health system. The central approval needs to be trusted to reduce the need for further approval.

Streamlining the Pathway and Increasing Transparency.

SME’s have difficulty tackling regulatory requirements due to fewer staff Dent explained, it’s less that there is a lack of transparency and more that regulation is overly complicated and clunky. She considered that, perhaps, starting from scratch would be best, beginning with the end goal and working backwards.

Final thoughts: Health, Care and Life Sciences Research Group

As the Research Group continues the first phase of the Life Sciences Industrial Strategy Programme (and looks into launching similar work on oncology), we invite thought leaders to get involved.

We thank lead sponsors of the Programme: IQVIA and Genomics Plc.

Curia’s interim report will be launched after Easter, where we will be inviting supporters of Curia and members of the Research Group to attend. You can sign up to the Curia Newsletter here to be kept informed about our events and reports. Furthermore, members of the Research Group will gain access to the full work of the Programme, including the full recording of the inquiry session.

Finally, with the aim to showcase how to turn policy into practice, the Curia team are always interested in receiving case studies of best practice that may feed into this work. If you or a colleague might know about a case where policy was effectively delivered into practice, please send details of the case study with learnings to team@curiauk.com. These will be shared with our Research Group Advisory Board, leaders in the NHS/public sector and Health, Care and Life Sciences Research Group members.

This article was written by Joshua Coyle

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